Alternative Approaches for Nausea Control

Not Applicable

Completed

• Conditions: Nausea
• Interventions: Device: Acupressure bands; Other: Expectancy-neutral handout; Other: Expectancy-enhancing handout; Behavioral: Expectancy-enhancing MP3; Behavioral: Expectancy-neutral MP3

• Registration Number: NCT01695993
• Lead Sponsor: University of Rochester

Brief Summary

216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.

Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea

Detailed Description

Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-28
• Study Start: 2012-11
• Primary Completion: 2017-05-16
• Study Completion: 2017-05-16
• Results First Submitted: 2018-03-27
• Results First Submitted QC: 2018-04-27
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Results First Posted: 2018-05-25
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 242

Inclusion Criteria

• Be female.

• Have a diagnosis of breast cancer, any stage.

• Be chemotherapy naïve and about to begin her first course of chemotherapy.

• Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:

  1. Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
  2. Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
  3. Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
  4. Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.

Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.

• Have a response of > 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = "I am certain I WILL NOT have this," and at the other end by 5 = "I am certain I WILL have this."
• Be able to read English (since the assessment materials are in printed format).
• Be 18 years of age or older and give written informed consent.

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Exclusion Criteria

• Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
• Be receiving concurrent radiotherapy or interferon.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3 - Expectancy-enhancing Arm	Acupressure bands	Patients receive: 1. Expectancy-enhancing handout 2. Expectancy-enhancing MP3 3. Acupressure bands
Arm 2 - Expectancy-neutral Arm	Expectancy-neutral handout	Patients receive: 1. Expectancy-neutral handout 2. Expectancy-neutral MP3 3. Acupressure bands
Arm 2 - Expectancy-neutral Arm	Acupressure bands	Patients receive: 1. Expectancy-neutral handout 2. Expectancy-neutral MP3 3. Acupressure bands
Arm 3 - Expectancy-enhancing Arm	Expectancy-enhancing MP3	Patients receive: 1. Expectancy-enhancing handout 2. Expectancy-enhancing MP3 3. Acupressure bands
Arm 2 - Expectancy-neutral Arm	Expectancy-neutral MP3	Patients receive: 1. Expectancy-neutral handout 2. Expectancy-neutral MP3 3. Acupressure bands
Arm 3 - Expectancy-enhancing Arm	Expectancy-enhancing handout	Patients receive: 1. Expectancy-enhancing handout 2. Expectancy-enhancing MP3 3. Acupressure bands

Primary Outcome Measures

Name	Time	Method
Patient Report Nausea Diary	five days	Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The outcome variable for the primary analysis was greatest reported nausea from the five day period.

Trial Locations

Locations (4)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

University of Rochester James P. Wilmot Cancer Center; 🇺🇸 Rochester, New York, United States

Hematology-Oncology Associates of Central New York; 🇺🇸 East Syracuse, New York, United States

Rochester General Hospital's Lipson Cancer and Blood Center; 🇺🇸 Rochester, New York, United States